FDA cracks down on kratom
The FDA on Wednesday announced the voluntary destruction and recall of a large volume of kratom-containing products marketed as dietary supplements that were manufactured and distributed under the brand names Botany Bay, Enhance Your Life and Divinity by Divinity Products Distribution of Grain Valley, Missouri.
In cooperation with the FDA, the company has also agreed to stop selling all products containing kratom. Based on the scientific evidence of the serious risks associated with the use of kratom, in the interest of public health, the FDA encourages all companies currently involved in the sale of products containing kratom intended for human consumption to take similar steps to take their products off the market and submit any necessary evidence, as appropriate, to the FDA to evaluate them based on the applicable regulatory pathway.
“The extensive scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death. At the same time, there’s no evidence to indicate that kratom is safe or effective for any medical use,” FDA Commissioner Scott Gottlieb said. “To protect the public health, we’ll continue to affirm the risks associated with kratom, warn consumers against its use and take aggressive enforcement action against kratom-containing products. We appreciate the cooperation of companies currently marketing any kratom product for human consumption to take swift action to remove these products from circulation to protect the public.”
When intended for use as or in a dietary supplement, the FDA considers kratom to be a new dietary ingredient. Generally, any dietary supplement containing kratom would need to be the subject of a New Dietary Ingredient Notification demonstrating that the product will reasonably be expected to be safe. To date, the FDA is not aware of any evidence of safety establishing that kratom (or any compounds derived from kratom) will reasonably be expected to be safe as a dietary ingredient. Additionally, kratom should not be used to treat any medical conditions, nor should it be used as an alternative to prescription opioids.
There are currently no FDA-approved therapeutic uses of kratom and importantly, the FDA has evidence to show that there are significant safety issues associated with its use. Before it can be legally marketed for therapeutic uses in the U.S., kratom’s risks and benefits must be evaluated as part of the regulatory process for drugs established by Congress.
“We know that some patients are using kratom because they believe it can help treat their opioid dependency, but there’s no reliable evidence to support kratom’s effectiveness for this use; and we’re deeply committed to making sure patients have access to safe, effective treatment options,” Gottlieb said. “There are three FDA-approved products that are safe and effective for the treatment of opioid use disorder and we encourage patients to seek advice from their health care professional and pursue treatment for addiction. Additionally, the FDA is taking new steps to bring new, safe and effective, FDA-approved therapies to the market for treatment of opioid use disorder. We understand that patients suffering from opioid addiction need access to effective treatment options. Creating an efficient pathway for the development of these treatments is a very high priority of mine.”
The FDA recommends that consumers not use these or any kratom products and dispose of any products currently in their possession.
In cooperation with the FDA, the company has also agreed to stop selling all products containing kratom. Based on the scientific evidence of the serious risks associated with the use of kratom, in the interest of public health, the FDA encourages all companies currently involved in the sale of products containing kratom intended for human consumption to take similar steps to take their products off the market and submit any necessary evidence, as appropriate, to the FDA to evaluate them based on the applicable regulatory pathway.
“The extensive scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death. At the same time, there’s no evidence to indicate that kratom is safe or effective for any medical use,” FDA Commissioner Scott Gottlieb said. “To protect the public health, we’ll continue to affirm the risks associated with kratom, warn consumers against its use and take aggressive enforcement action against kratom-containing products. We appreciate the cooperation of companies currently marketing any kratom product for human consumption to take swift action to remove these products from circulation to protect the public.”
When intended for use as or in a dietary supplement, the FDA considers kratom to be a new dietary ingredient. Generally, any dietary supplement containing kratom would need to be the subject of a New Dietary Ingredient Notification demonstrating that the product will reasonably be expected to be safe. To date, the FDA is not aware of any evidence of safety establishing that kratom (or any compounds derived from kratom) will reasonably be expected to be safe as a dietary ingredient. Additionally, kratom should not be used to treat any medical conditions, nor should it be used as an alternative to prescription opioids.
There are currently no FDA-approved therapeutic uses of kratom and importantly, the FDA has evidence to show that there are significant safety issues associated with its use. Before it can be legally marketed for therapeutic uses in the U.S., kratom’s risks and benefits must be evaluated as part of the regulatory process for drugs established by Congress.
“We know that some patients are using kratom because they believe it can help treat their opioid dependency, but there’s no reliable evidence to support kratom’s effectiveness for this use; and we’re deeply committed to making sure patients have access to safe, effective treatment options,” Gottlieb said. “There are three FDA-approved products that are safe and effective for the treatment of opioid use disorder and we encourage patients to seek advice from their health care professional and pursue treatment for addiction. Additionally, the FDA is taking new steps to bring new, safe and effective, FDA-approved therapies to the market for treatment of opioid use disorder. We understand that patients suffering from opioid addiction need access to effective treatment options. Creating an efficient pathway for the development of these treatments is a very high priority of mine.”
The FDA recommends that consumers not use these or any kratom products and dispose of any products currently in their possession.